A Placebo Controlled Randomised Study of Balloon Sinuplasty Efficiency in Chronic or Recurrent Maxillary Rhinosinusitis

What this Trial Is About

Researchers are evaluating the effects of balloon sinuplasty treatment compared to a placebo in adults with chronic or recurrent maxillary sinusitis without nasal polyposis. The study aims to determine how effective balloon sinuplasty is in treating maxillary sinusitis and to identify which patients may benefit most. Additionally, the study investigates whether balloon sinuplasty improves Eustachian tube dysfunction. A total of 120 patients are enrolled, divided equally between chronic and recurrent maxillary sinusitis groups, with random assignment to either balloon sinuplasty or placebo treatment. The treatments are performed under local anesthesia in a day surgery setting. In the balloon sinuplasty group, a flexible balloon device is inserted and inflated in the maxillary sinus ostium to dilate it, while the placebo group undergoes a sham procedure mimicking the balloon inflation without the actual treatment. Both groups have the procedure performed on both maxillary sinuses. The study staff and patients are kept unaware of the treatment assignment to maintain blinding. Patients are followed for 12 months after the operation, with evaluations at 3, 6, 9, and 12 months. Participants complete questionnaires including the Sino-Nasal Outcome Test (SNOT-22) and the Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Clinical assessments include nasal endoscopy, rhinomanometry, tympanometry, tubomanometry, and Cone Beam Computed Tomography (CBCT) scans before and after treatment. Biopsies of nasal mucosa are taken during the operation and after 12 months. Researchers also track sinus infection episodes, antibiotic use, sick leaves, and symptom severity using visual scales. The study's primary outcomes focus on changes in quality of life and infection frequency, with safety and effectiveness monitored throughout.

Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.